Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of trabectedin (yondelis®) in patients with advanced soft tissue sarcoma

Conditions: Soft Tissue Sarcoma

Summary: efficacy and safety of trabectedin in real-life practice, routinely used for the management of advanced sarcoma after failure of anthracyclines and ifosfamide or patients unsuited to receive these drugs in germany. trabectedin is indicated for the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. efficacy data are based mainly on liposarcoma and leiomyosarcoma patients.

this is a non-interventional, observational and prospective study to evaluate efficacy and safety of trabectedin in routine practice. patients are assigned to a therapeutic strategy within current practice, not according to a trial protocol. the prescription of the medicine is separated from the decision to include the patient in the study. diagnostic or monitoring procedures are only those ordinarily applied to the therapeutic strategy. there are no dose regimens or medical procedures defined within this study plan. every medical decision and course of treatment with trabectedin will reflect exclusively the decision of the investigator in a routine clinical situation according to smpc. the concept of this non-interventional study and its documentation procedure will not affect in any way the routine treatment situation.

Eligibility criteria:
inclusion criteria: * patients must comply with all of the following criteria in order to be enrolled into the study: * histologically diagnosed advanced sts * female or male aged 18 years or above * signed written informed consent * suitable to undergo treatment with trabectedin according to smpc * progress after therapy with anthracyclines and ifosfamide has failed, or if patients are unsuited to receive these agents exclusion criteria: * patients presenting contraindications for the use of trabectedin as defined in the smpc will be excluded from participating in the study.
validating the "foods for health" portfolio of functional food products

Conditions: Hypercholesterolemia

Summary: the objective of this research project is to investigate the ability to affect cardiovascular disease (cvd) risk factors through a novel, easily implemented functional food-based approach. the goal of the proposed project is to evaluate the effect of a range of proprietary products specifically formulated to deliver convenient pre-packaged condition-specific foods to positively impact blood cholesterol levels in statin intolerant and/or statin unwilling participants. the specific aim of this project is to evaluate the changes in serum low-density lipoprotein (ldl)-cholesterol, triglyceride (tg) glucose, insulin and high-sensitivity c-reactive protein (hscrp) concentrations over a 4 week regimen using healthy tasty foods which are self-selected by a statin intolerant patient group.


Eligibility criteria:
inclusion criteria: participants aged \> 21 to \< 65 years will be recruited on the basis of ability to give informed consent and being unwilling to use or intolerant of at-least one statin medication. exclusion criteria: participants will be excluded if they are unable to speak/read in english or are unable or unwilling to temporarily hold all statin/lipid lowering therapies including supplements throughout the study period. participants with diabetes or severe obesity (body mass index, bmi, \> 35 kg/m2) will be excluded. women who are pregnant or planning to be pregnant during the study period will not be eligible for the study. participants with any food allergies/intolerances, food restrictions due to medical, religious or philosophical reason - including kosher, vegan, vegetarian, high protein, low-carbohydrate, low-phosphorus, etc. other than attempting to follow an eating plan as generally advocated by the american heart association (low sodium, low cholesterol, reduced fat, etc.) will be excluded. participants will not be eligible if their baseline fasting ldl-c is \ 190 mg/dl; or evidence of tissue cholesterol deposition; if their baseline fasting tg is \> 400 mg/dl or baseline fasting blood glucose is \> 126 mg/dl. consumption of more than 2 alcoholic drink/day or history of alcoholism or drug dependence will also serve as an exclusion criterion. smokers will be excluded from the study. history of non-skin cancer, history of melanoma, history of rheumatoid arthritis or other chronic rheumatologic condition, history of advanced cardiovascular disease (moderate or greater valvular disease, history congestive heart failure, known coronary artery disease, history dysrhythmias requiring medical or surgical intervention), , known chronic liver or renal disease, diabetes, inflammatory bowel disease, celiac disease, uncontrolled thyroid disease, hormonal supplementation(other than thyroid), pancreatitis, gallbladder or biliary disease, neurological/psychological disease, and gastrointestinal disorders that could interfere with fat absorption will be excluded. individuals with uncontrolled hypertension having systolic blood pressure \>150 mm hg or diastolic blood pressure \>100 mm hg will be excluded from the study.
symptoms and outcome measures for upper- limb function in myotonic dystrophy type 1

Conditions: Myotonic Dystrophy 1

Summary: myotonic dystrophy type 1 (dm1) is a multisystem disease that causes muscle weakness and myotonia. as a result upper limb function might become impaired. in this study we will examine patients with dm1 and record their upper limb function. we will will use a battery of patient reported outcomes (pros) and outcome measures (oms) in order to evalute which ones are suitable for use in clinical practise and research studies.


Eligibility criteria:
inclusion criteria: • genetically confirmed myotonic dystrophy type 1 exclusion criteria: * unable to answer or understand questionnaires due to language barriers or cognitive status * unable to perform functional tests

Keywords: outcome measure patient reported outcome upper limb function arm- and hand function symptoms
safety and tolerability of typhoid conjugate vaccine (eutcv) in healthy adults

Conditions: Typhoid Fever

Summary: the purpose of this study is to evaluate the safety and tolerability of eutcv, in comparison to tcv (typbar-tcv™, bharat biotech) and vi-polysaccharide vaccine (typhim vi®, sanofi pasteur) in healthy adult volunteers.


Eligibility criteria:
inclusion criteria: 1. subjects aged between and including 18 and 45 years at time of visit 1 2. subjects willing to give written informed consent to participate in the trial 3. subjects who are healthy as determined by medical history, with no clinically significant abnormalities in clinical examination and laboratory tests exclusion criteria: 1. subjects unwilling to give his/her consent to participate in the trial 2. subjects who have received typhoid containing vaccines 3. subjects who have past history of typhoid 4. subjects already immunized with any licensed vaccine within 4 weeks 5. subjects with known hypersensitivity to any component of the study vaccine 6. subjects who are pregnant, lactating or childbearing age not using a reliable method of contraception 7. subjects with any abnormality or chronic disease 8. subjects with evidence of acute illness within past 7 days requiring systemic antibiotic or antiviral therapy 9. subjects who have experienced transient thrombocytopenia or neurological complications following an earlier immunization against diphtheria and/or typhoid 10. subjects who have known history of immune function disorders 11. subjects who have known history of administration of blood or blood-derived products 12. subjects who have history of alcohol or substance abuse
effect of modeling resin on anterior direct composite veneer

Conditions: Dental Wear; Dental Decay

Summary: the study will be conducted to evaluate the clinical performance of direct nanohybrid resin composite veneer restorations applied with or without modeling resin

chatgpt this study aims to investigate the impact of modeling resin on the clinical performance of direct nanohybrid resin composite veneer restorations in anterior teeth. resin composites are widely used in dental restorations due to their aesthetic qualities, but issues like discoloration and surface roughness can affect their longevity and patient satisfaction. modeling resin, used to aid in composite placement and sculpting, has become common, but concerns exist regarding its effects on composite properties, particularly long-term color stability. the research will employ a randomized controlled trial design with a two-arm parallel approach. adult patients (18-45 years) with anterior tooth defects suitable for composite veneer restoration will be recruited. the intervention group will receive nanohybrid resin composite with modeling resin, while the comparator group will receive the composite without modeling resin. outcomes will be assessed using modified usphs criteria, including color stability, color match, anatomical form, marginal adaptation, marginal discoloration, retention rate, presence of secondary caries, and postoperative sensitivity, at baseline and at follow-up intervals of 1, 3, 6, and 12 months. statistical analysis will involve independent t-tests for intergroup comparisons and repeated measures anova for intragroup comparisons, with a significance level set at 0.05. the study aims to determine if the use of modeling resin influences the clinical outcomes of resin composite veneer restorations. ethics approval will be obtained, and confidentiality of participant data will be strictly maintained throughout the study period. overall, this research seeks to provide insights into optimizing the application of resin composites in dental practice to enhance patient outcomes and satisfaction

Eligibility criteria:
inclusion criteria: * • adults (18-45ys) with anterior tooth defects indicated for direct composite veneer restoration. * males or females. * community-dwelling * have all his/her anterior teeth with sufficient enamel structure * with ≥ 1 anterior tooth defect * have sufficient cognitive ability to understand consent procedures * anterior tooth defect indicated for direct composite veneer * vital upper or lower anterior teeth with no signs or symptoms of irreversible pulpitis. * mobility grade: no clinical mobility * plaque index ≤ 2 exclusion criteria: * patients younger than 18 or older than 45 years old • disabilities. * systemic diseases or severe medically compromised. * lack of compliance. * evidence of severe bruxism, clenching or temporomandibular joint disorders. * cognitive impairment periapical pathosis or signs of pulpal pathology. * malocclusion * possible prosthodontic restoration within 1 year. * non-vital tooth. * endodontically treated tooth. * severe periodontal affection or tooth indicated for extraction.
simplified nutritional screening for patient use

Conditions: Malnutrition

Summary: the purpose of this study is to determine if patients are able to reliably screen themselves for nutrition risk.


Eligibility criteria:
inclusion criteria: * male or female * adults aged \> 18years * able to complete screening and provide written informed consent * willingness to take part exclusion criteria: * children (\<18years) * pregnant women * inpatients * unable to complete screen due to physical or mental incapacity * unable to comprehend oral and written english language * participation in other nutrition studies

Keywords: nutrition screening
motor and cognitive functions in acquired and developmental brain damaged patients

Conditions: Cerebral Palsy; Perceptual Disorders; Hemiparesis

Summary: neurological pathologies cause important and permanent disabilities in every day life. these pathologies can follow stoke, affecting two people per one thousand each year or cerebral palsy, affecting two births per one thousand each year. to date, the diagnosis and the rehabilitation of motor and cognitive problems has been carried out separately by different domains. for example, physiotherapists have focused on motor problems and neuropsychologists have focused on cognitive functions. however, a number of studies have demonstrated a link between motor and cognitive abilities in adults and children. the present study has three main aims: (1) to better evaluate motor and cognitive problems in brain damaged patients (all ages), (2) to understand the link between motor and cognitive abilities in patients and healthy participants and, (3) to propose new types of therapies based on the link between motor and cognitive functions.


Eligibility criteria:
inclusion criteria: * congenital cerebral palsy and acquired brain injury children and adult patients * presenting upper limb paresis and/or hemineglect * between the age of 3 to 90. * able to understand and carry out simple verbal instruction exclusion criteria: * iq \< 70 * severe aphasia, attentional disorder or psychiatric disorders * neurodegenerative disorders
efficacy of fractional microneedle radiofrequency and fractional erbium-doped glass 1,565-nm for baggy lower eyelids

Conditions: Photoaging

Summary: the purpose of this study was to compare the efficacy and safety of fmr and nafl in the treatment of baggy lower eyelids(bles)

fifteen baggy lower eyelids(bles) volunteers were recruited prospectively. everyone was divided into two groups with fmr and nafl according to the random number table. one side of the face was treated with fmr device and the other side was treated with nafl device. subjective and objective adverse reactions were recorded during the operation. subjective adverse reactions were recorded after each treatment. the vas score of patient satisfaction and the blind method score of standard photo observer were used for subjective evaluation, and the objective evaluation was carried out by using visia，antera-3d and cinescan.

Eligibility criteria:
inclusion criteria: 1. patients with bags lower eyelids ( bles )； 2. two senior attending surgeons diagnosed the bles; 3. the clinical diagnosis standard was mild swelling or puffiness under the eyes; 4. between 18 to 60 years old. exclusion criteria: 1. history of retinoic acid; 2. history of hormone use; 3. history of keloids; 4. history of injection of botulinum toxin or filler at the site of treatment; 5. skin inflammation or facial infection; 6. pregnancy or lactation.
treating alcohol use in older adults with depression

Conditions: Alcoholism; Depression

Summary: the purpose of this study is to test the efficacy combining a treatment for depression with a treatment for alcohol dependence.

this study aims to study 80 patients with comorbid alcohol dependence and a depressive syndrome. after appropriate detoxification, patients are started on either naltrexone 50 mg or placebo. after one week, sertraline is added in an open label fashion. it is hypothesized that those patients receiving combination therapy will last 3 months with follow-up tracking lasting 1 year.

Eligibility criteria:
inclusion criteria: * age \> 55 * current depressive syndrome * current alcohol dependence * no psychosis * no opioid or cocaine abuse or dependence exclusion criteria:
effect of kinesio tape on motor function in subjects with acl rupture

Conditions: ACL Rupture; Rehabilitation

Summary: thirty-two participants with acl rupture were included in the study. all participants were divided in two groups - control and experimental. in the experimental group (n=16) participants received 4 weeks standardized physiotherapy and kinesio tape, in the control group - standardized physiotherapy. experimental measurements: anthropometric measurements, pain intensity, static and dynamic balance, proprioception, knee flexion and extension muscle torque, level of activity


Eligibility criteria:
inclusion criteria: 1. 18 - 35-year-old men; 2. a normal contralateral knee, 3. not a longer period than 3 months after acl rupture. exclusion criteria: participants were excluded if either knee had previously been injured or had undergone surgery, if they had concurrent osteoarthritis, if they had injured the posterior cruciate ligament, lateral collateral ligament, or posterolateral complex of the knee, or if they had a grade iii tear of the medial collateral ligament.
rna biomarkers in tissue samples from infants with acute myeloid leukemia

Conditions: Leukemia

Summary: rationale: studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in rna and identify biomarkers related to cancer. purpose: this research study is studying rna biomarkers in tissue samples from infants with acute myeloid leukemia.

objectives: * sequence the micrornas present in 20 infant aml samples as a pilot study. * compare micrornas present in infant aml samples to infant all samples that are being concurrently sequenced in a separate study to identify lineage- and translocation-specific micrornas. outline: this is a multicenter study. previously collected cryopreserved cells from diagnosis are sequenced using reverse transcriptase-pcr.

Eligibility criteria:
disease characteristics: * diagnosis of acute myeloid leukemia * available cryopreserved cells from diagnosis patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: childhood acute myeloid leukemia/other myeloid malignancies
improvement of quality of life in patients using low-dose pills in the different phases of menacme

Conditions: Quality of Life; Menopause; Contraception

Summary: the purpose of this study is to determine whether low-dose contraceptive pills are effective in the improvement of quality of life in patients in the different phases of menacme.


Eligibility criteria:
inclusion criteria: * fertile women with indication of use of contraceptive pills exclusion criteria: * fertile women with any surgical contraceptive method * women in menopause * diseases the forbidden the use of the drug

Keywords: quality of life menopause contraception
treatment and prognosis of neurogenic orthostatic hypotension : a prospective randomized study

Conditions: Orthostatic; Hypotension, Neurogenic

Summary: compare the effect of treatment of midodrine and pyridostigmine in neurogenic orthostatic hypotension and investigate the quality of life of treatment of neurogenic orthostatic hypotension.

in patients with neurogenic orthostatic hypotension, the appropriate treatment was identified by comparing the treatment effects and side effects for each treatment drug. in addition, by confirming the effect of orthostatic hypotension on lowering the quality of life, it is expected that the improvement of the quality of life will help.

Eligibility criteria:
inclusion criteria: * age \>=18 patients who complained of dizziness * orthostatic hypotension after 3-minute standing (systolic blood pressure drop \>=20 or diastolic blood pressure drop \>=10 exclusion criteria: * drug-induced hypotension, if necessary, evaluate patient after discontinuing the causative drug for one month * heart failure or chronic renal failure * patients who cannot or do not want to write questionaires. * poor drug compliance
stereotactic ablative radiotherapy for hepatocellular carcinoma ≤ 5 cm

Conditions: Hepatocellular Carcinoma

Summary: the standard treatment for hepatocellular carcinoma (hcc) is surgery, such as, by hepatic resection or liver transplantation, but less than 20% of hcc patients are suitable for surgery. in the remaining patients with inoperable and advanced hcc, trans-arterial chemo-embolization (tace) has been widely used but tace alone rarely produces complete response and commonly develops recurrence. recently several small studies reported high tumor response and local control rate after stereotactic ablative radiotherapy (sabr) alone or with tace for inoperable hcc. this study will evaluate sabr effect with 60 gy in 3 fractionations for hcc with size of ≤ 5 cm and 3 cm apart from gastrointestinal tract.


Eligibility criteria:
inclusion criteria: * male or female patients ≥ 20 years of age * initially diagnosed or recurrent hepatocellular carcinoma (hcc) * unresectable hcc * cirrhotic status of child pugh class a or b7 * eastern cooperative oncology group performance status 0 or 1 * single or sum of multiple tumor ≤ 5 cm * hcc with 3 cm apart from gastrointestinal tract * the volume of uninvolved must be at least 700 ml * incomplete response after trans-arterial chemo-embolization of 1-5 * a single lesion or multiple lesions including portal vein tumor thrombosis included in radiation field with one or consecutive sessions of stereotactic body radiation therapy (sbrt) * no evidence of an uncontrolled lesion at any other site * no evidence of complications of liver cirrhosis * no evidence of uncontrolled inter-current illness * patient or guardian must be able to provide verbal and written informed consent exclusion criteria: * patient with previous history of abdominal radiation * direct invasion to esophagus, stomach or colon by hcc

Keywords: hepatocellular carcinoma stereotactic ablative radiotherapy stereotactic body radiotherapy
evaluation of clp in heart failure patients with chronic kidney disease

Conditions: Heart Failure

Summary: the purpose of this study is to determine the effects of clp on serum potassium and signs and symptoms of fluid overload in heart failure patients with chronic kidney disease.


Eligibility criteria:
inclusion criteria: * heart failure with new york heart association (nyha) classification iii or iv * hospitalization for heart failure decompensation associated with fluid overload within the last six months * chronic kidney disease * must be able to understand study procedures and willing and able to provide written informed consent exclusion criteria: * no hospitalization within 4 weeks of baseline visit * in the investigator's judgment, any cardiovascular, renal, hepatic, endocrine, gastrointestinal, neurological or other disease or condition that makes the patients study participation unsafe * history or presence of gastrointestinal conditions such as severe constipation or gastrointestinal tract strictures * current dialysis patient, or anticipated need for dialysis during study participation
peg-intron for prevention of disease progress in chronic hepatitis c patients with cirrhosis (study p02569)

Conditions: Chronic Hepatitis C; Cirrhosis

Summary: the objective of the study is to evaluate the safety and efficacy of peg-intron vs. no treatment for the prevention of disease progression in adult subjects with compensated cirrhosis secondary to chronic hepatitis c, who failed to respond to therapy with an a interferon plus ribavirin.


Eligibility criteria:
inclusion criteria: * age at entry 18-65 years; * non-responders to previous treatment (minimum of 3 months) with an alpha interferon plus ribavirin; * liver biopsy demonstrating cirrhosis exclusion criteria: * any other cause for liver disease other than chronic hepatitis c; * history or presence of complications of cirrhosis; * alcohol or illicit drug abuse or treatment with methadone within the past 2 years; * diseases or conditions that could interfere with participation in the study

Keywords: hepatitis c; cirrhosis